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Performance Hyperbarics
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FLEXI-LITE, MODEL FL-V1.2 is an FDA 510(k)-cleared medical device (K051759) manufactured by Performance Hyperbarics. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2005. Regulation: 8.